The failure occurs if a user on the Omnipod 5 iOS recall
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the…
Why was The failure occurs if a user on the Omnipod 5 iOS recalled?
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X
- Product
- The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the…
- Recalling firm
- Insulet Corporation
- Quantity
- 174,013 units
- Distribution
- US Nationwide distribution.
- Recall date
- October 22, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)